The Effect of a Single Intravenous Injection of Esketamine During Cesarean Section on Postoperative Pruritus in Patients With Intrahepatic Cholestasis of Pregnancy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Normal Saline (0.9% NaCl), Esketamine 0.3mg/kg.
- Who it may be relevant to
- Registry conditions: Intrahepatic Cholestasis of Pregnancy. Basic parameters: 18 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effect of a Single Intravenous Injection of Esketamine During Cesarean Section on Postoperative Pruritus in Patients With Intrahepatic Cholestasis of Pregnancy:A Single-center Randomized Controlled Trial
Overview
To explore the effect of a single intravenous injection of esketamine during cesarean section on postoperative pruritus in patients with intrahepatic cholestasis of pregnancy.
Detailed description
Intrahepatic cholestasis of pregnancy (ICP) is an important obstetric complication that occurs in the middle and late stages of pregnancy, characterized mainly by pruritus and elevated serum total bile acid (TBA) levels.
Pruritus usually begins on the palms and soles of the feet and can gradually spread. It typically shows a 'lighter during the day and heavier at night' pattern, severely affecting the patient's quality of life. It can also lead to physical and psychological disorders, and even cause mental abnormalities and self-harming behaviors in patients.
Esketamine is the right-handed isomer of ketamine and is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist. It has the effects of rapid pain relief, rapid antidepressant action, sedation, and improvement of sleep. Relevant studies have shown that the NMDA receptor may play an important role in the transmission of non-histaminergic itching. Eslicarbazepine acetate, as a highly selective NMDA receptor antagonist, may alleviate the transmission and propagation of itching. However, there are no reports on whether a single intravenous injection of esketamine can alleviate the pruritus symptoms of patients with pregnancy-induced intrahepatic cholestasis. This experiment aims to investigate the effect of a single intravenous injection of esketamine during cesarean section on postoperative pruritus in patients with pregnancy-induced intrahepatic cholestasis.
Interventions
- Drug Normal Saline (0.9% NaCl)
The same volume of normal saline was injected after fetal delivery during the operation - Drug Esketamine 0.3mg/kg
Esketamine 0.3mg/kg was given intravenously after fetal delivery during the operation
Primary outcome measures
- NRS pruritus score at 24 hours after surgery [Time frame: 24 hours after the surgery]
Secondary outcome measures (12)
- 5-D itch scale at 72 hours after surgery [Time frame: 72 hours after surgery]
- NRS pruritus score at 6 hours、12 hours、48 hours、72h ours and the seventh day after surgery [Time frame: 6 hours、12 hours、48 hours、72 hours and the seventh day after surgery]
- The incidence of pruritus on the 24 hours after surgery [Time frame: 24 hours after surgery]
- Total bile acid at 24 hours after surgery [Time frame: 24 hours after surgery]
- Pain Score (NRS) [Time frame: 6 hours, 12 hours, 24 hours, 48 hours, 72 hours after the surgery]
- The incidence of postoperative sleep disturbance on the first、second and third postoperative nights [Time frame: the first、second and third nights after surgery]
- Postoperative anxiety [Time frame: 72 hours after the surgery]
- Postoperative depression [Time frame: 72 hours after the surgery]
- Key time points of the surgery [Time frame: Perioperative period]
- Intraoperative average blood pressure（mmHg） [Time frame: Perioperative period]
- Intraoperative average heart rate（times per minute） [Time frame: Perioperative period]
- Intraoperative average blood oxygen saturation（%） [Time frame: Perioperative period]
Eligibility criteria
Inclusion criteria
- Age: 18 - 40 years old; Gestational age: ≥ 35 weeks; Singleton pregnancy.
- Clear consciousness, able to cooperate with NRS scoring, laboratory tests and follow-up.
- Meet the diagnostic criteria of the "Clinical Diagnosis, Treatment and Management Guidelines for Intrahepatic Cholestasis of Pregnancy (2024 Edition)" : fasting serum TBA≥10 μmol/L or postprandial serum TBA≥19 μmol/L.
- Reporting pruritus NRS ≥ 4 points twice within one week.
- Planned to undergo cesarean section under intraspinal anesthesia.
- ASA classification: I - III grade.
Exclusion criteria
- Those who are known to be allergic to the drug components or have an allergic constitution.
- Related to the safe use of esketamine: history of mental illness; uncontrolled hypertension; uncontrolled hyperthyroidism; increased intracranial pressure, increased intraocular pressure; long-term alcohol consumption or drug abuse history.
- Those with severe organic diseases and liver diseases.
- Those with malignant tumors.
- Other pruritic diseases: uremic pruritus, true erythrocytosis, cutaneous T-cell lymphoma, eosinophilia, drug rash and drug-induced pruritus, and other pruritic diseases that are easily confused, such as atopic dermatitis, pemphigus, scabies, parasitic delusionism, artificial dermatitis, etc.
- Eclampsia and pre-eclampsia, HELLP syndrome; fetal developmental abnormalities, multiple pregnancies.
- ASA classification as grade IV.
- Those with poor compliance and unable to complete the trial according to the research protocol.
- Those who have participated in other drug clinical trials within the past 4 weeks.
- Due to any reason, the researchers consider that there is any situation that is not suitable for inclusion.
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Tianjin Medical University General Hospital — Tianjin
Identifiers
NCT: NCT07560722 · IRB2026-YX-129-01